(a) Administrator, without qualification, means the Administrator of the Environmental Protection Agency.
(b) Agency, without qualification, means the Environmental Protection Agency.
(c) FFDCA means the Federal Food, Drug, and Cosmetic Act, as amended, 21 U.S.C. 301-392.
(d) Raw agricultural commodities include, among other things, fresh fruits, whether or not they have been washed and colored or otherwise treated in their unpeeled natural form; vegetables in their raw or natural state, whether or not they have been stripped of their outer leaves, waxed, prepared into fresh green salads, etc.; grains, nuts, eggs, raw milk, meats, and similar agricultural produce. It does not include foods that have been processed, fabricated, or manufactured by cooking, freezing, dehydrating, or milling.
(e) Where a raw agricultural commodity bearing a pesticide chemical residue that has been exempted from the requirement of a tolerance, or which is within a tolerance permitted under FFDCA section 408, is used in preparing a processed food, the processed food will not be considered unsafe within the meaning of FFDCA sections 402 and 408(a), despite the lack of a tolerance or exemption for the pesticide chemical residue in the processed food, if:
(1) The pesticide chemical has been used in or on the raw agricultural commodity in conformity with a tolerance under this section;
(2) The pesticide chemical residue has been removed to the extent possible in good manufacturing practice; and
(3) The concentration of the pesticide chemical residue in the processed food is not greater than the tolerance prescribed for the pesticide chemical residue on the raw agricultural commodity.
(f) For the purpose of computing fees as required by Sec. 180.33, each group of related crops listed in Sec. 180.34(e) and each crop group or subgroup listed in Sec. 180.41 is counted as a single raw agricultural commodity in a petition or request for tolerances or exemption from the requirement of a tolerance.
(g) Tolerances and exemptions established for pesticide chemicals in or on the general category of raw agricultural commodities listed in column A apply to the corresponding specific raw agricultural commodities listed in column B. However, a tolerance or exemption for a specific commodity in column B does not apply to the general category in column A. ------------------------------------------------------------------------
A B------------------------------------------------------------------------Alfalfa Medicago sativa L. Subsp. sativa,
(alfalfa, lucerne); Onobrychis
viciifolia Scop. (sainfoin, holy
clover, esparcet); and Lotus
corniculatus L. (trefoil); and
varieties and/or hybrids of
these.------------------------------------------------------------------------Banana Banana, plantain.------------------------------------------------------------------------Bean Cicer arietinum (chickpea,
garbanzo bean); Lupinus spp.
(including sweet lupine, white
sweet lupine, white lupine, and
grain lupine). Phaseolus spp.
(including kidney bean, lima
bean, mung bean, navy bean, pinto
bean, snap bean, and waxbean;
Vicia faba (broad bean, fava
bean); Vigna spp. (including
asparagus bean, blackeyed pea and
cowpea).------------------------------------------------------------------------Bean, dry All beans above in dry form only.------------------------------------------------------------------------Bean, succulent All beans above in succulent form
only.------------------------------------------------------------------------Blackberry Rubus eubatus (including
bingleberry, black satin berry,
boysenberry Cherokee blackberry,
Chesterberry, Cheyenne
blackberry, coryberry,
darrowberry, dewberry, Dirksen
thornless berry, Himalayaberry,
hullberry, Lavacaberry, lowberry,
Lucretiaberry, mammoth
blackberry, marionberry,
nectarberry, olallieberry, Oregon
evergreen berry, phenomenalberry,
rangerberry, ravenberry,
rossberry, Shawnee blackberry,
and varieties and/or hybrids of
these).------------------------------------------------------------------------
Broccoli Broccoli, chinese broccoli (gia
lon, white flowering broccoli).------------------------------------------------------------------------Cabbage Cabbage, Chinese cabbage (tight-
heading varieties only).------------------------------------------------------------------------Caneberry Rubus spp. (including blackberry);
Rubus caesius (youngberry);
Rubus loganbaccus (loganberry);
Rubus idaeus (red and black
raspberry); cultivars, varieties,
and/or hybrids of these.------------------------------------------------------------------------Celery Celery, Florence fennel (sweet
anise, sweet fennel, finochio)
(fresh leaves and stalks only).------------------------------------------------------------------------Cherry Cherry, sweet, and cherry, tart.------------------------------------------------------------------------Endive Endive, escarole.------------------------------------------------------------------------Fruit, citrus Grapefruit, lemon, lime, orange,
tangelo, tangerine, citrus
citron, kumquat, and hybrids of
these.------------------------------------------------------------------------Garlic Garlic, great headed; garlic, and
serpent garlic.------------------------------------------------------------------------Lettuce Lettuce, head; and lettuce, leaf------------------------------------------------------------------------Lettuce, head Lettuce, head; crisphead varieties
only------------------------------------------------------------------------Lettuce, leaf Lettuce, leaf; cos (romaine),
butterhead varieties------------------------------------------------------------------------Marjoram Origanum spp. (includes sweet or
annual marjoram, wild marjoram or
oregano, and pot marjoram).------------------------------------------------------------------------Melon Muskmelon, including hybrids and/
or varieties of Cucumis melo
(including true cantaloupe,
cantaloupe, casaba, Santa Claus
melon, crenshaw melon, honeydew
melon, honey balls, Persian
melon, golden pershaw melon,
mango melon, pineapple melon,
snake melon); and watermelon,
including hybrids and/or
varieties of (Citrullus spp.).------------------------------------------------------------------------Muskmelon Cucumis melo (includes true
cantaloupe, cantaloupe, casaba,
Santa Claus melon, crenshaw
melon, honeydew melon, honey
balls, Persian melon, golden
pershaw melon, mango melon,
pineapple melon, snake melon, and
other varieties and/or hybrids of
these.)------------------------------------------------------------------------Onion Bulb onion; green onion; and
garlic.------------------------------------------------------------------------Onion, bulb Bulb onion; garlic; great headed
garlic; serpent garlic; Chinese
onion; pearl onion; potato onion;
and shallot, bulb.------------------------------------------------------------------------Onion, green Green onion; lady's leek; leek;
wild leek; Beltsville bunching
onion; fresh onion; tree onion,
tops; Welsh onion; and shallot,
fresh leaves.------------------------------------------------------------------------Peach Peach, nectarine------------------------------------------------------------------------Pea Cajanus cajan (includes pigeon
pea); Cicer spp. (includes
chickpea and garbanzo bean); Lens
culinaris (lentil); Pisum spp.
(includes dwarf pea, garden pea,
green pea, English pea, field
pea, and edible pod pea). [Note:
A variety of pesticide tolerances
have been previously established
for pea and/or bean. Chickpea/
garbanzo bean is now classified
in both the bean and the pea
categories. For garbanzo bean/
chickpea only, the highest
established pea or bean tolerance
will apply to pesticide residues
found in this commodity.]------------------------------------------------------------------------Pea, dry All peas in dry form only.------------------------------------------------------------------------Pea, succulent All peas in succulent form only.------------------------------------------------------------------------Pepper All varieties of pepper including
pimento and bell, hot, and sweet
pepper.------------------------------------------------------------------------Radish, oriental, roots Raphanus sativus var.
longipinnatus (roots and tops),
including Chinese or Japanese
radish (both white and red),
winter radish, daikon, lobok, lo
pak, and other cultivars and/or
hybrids of these.------------------------------------------------------------------------
Radish, oriental, tops) Raphanus sativus var.
longipinnatus (roots and tops),
including Chinese or Japanese
radish (both white and red),
winter radish, daikon, lobok, lo
pak, and other cultivars and/or
hybrids of these.------------------------------------------------------------------------Rapeseed Brassica napus, B. campestris, and
Crambe abyssinica (oilseed-
producing varieties only which
include canola and crambe.)------------------------------------------------------------------------Raspberry Rubus spp. (including bababerry;
black raspberry; blackcap;
caneberry; framboise; frambueso;
himbeere; keriberry; mayberry;
red raspberry; thimbleberry;
tulameen; yellow raspberry; and
cultivars, varieties, and/or
hybrids of these).------------------------------------------------------------------------Sorghum, grain, grain Sorghum spp. [sorghum, grain,
sudangrass (seed crop), and
hybrids of these grown for its
seed].------------------------------------------------------------------------Sorghum, forage, stover Sorghum spp. [sorghum, forage;
sorghum, stover; sudangrass, and
hybrids of these grown for forage
and/or stover.------------------------------------------------------------------------Squash Pumpkin, summer squash, and winter
squash.------------------------------------------------------------------------Sugar apple Annona squamosa L. (sugar apple,
sweetsop, anon), and its hybrid
A. squamosa L. x A. cherimoya M.
(atemoya). Also A. reticulata L.
(true custard apple).------------------------------------------------------------------------Squash, summer Fruits of the gourd
(Cucurbitaceae) family that are
consumed when immature, 100% of
the fruit is edible either cooked
or raw, once picked it cannot be
stored, has a soft rind which is
easily penetrated, and if seeds
were harvested they would not
germinate; e.g., Cucurbita pepo
(i.e., crookneck squash,
straightneck squash, scallop
squash, and vegetable marrow);
Lagenaria spp. (i.e., spaghetti
squash, hyotan, cucuzza); Luffa
spp. (i.e., hechima, Chinese
okra); Momordica spp. (i.e.,
bitter melon, balsam pear, balsam
apple, Chinese cucumber); Sechium
edule (chayote); and other
cultivars and/or hybrids of
these.------------------------------------------------------------------------Sweet potato Sweet potato, yam.------------------------------------------------------------------------Tangerine Tangerine (mandarin or mandarin
orange); clementine;
Mediterranean mandarin; satsuma
mandarin; tangelo; tangor;
cultivars, varieties, and/or
hybrids of these.------------------------------------------------------------------------Tomato Tomato, tomatillo.------------------------------------------------------------------------Turnip tops or turnip greens Broccoli raab (raab, raab salad),
hanover salad, turnip tops
(turnip greens).------------------------------------------------------------------------Wheat Wheat, triticale.------------------------------------------------------------------------
(h) Unless otherwise specified in this paragraph or in tolerance regulations prescribed in this part for specific pesticide chemicals, the raw agricultural commodity or processed food to be examined for pesticide residues, shall consist of the whole raw agricultural commodity or processed food.
(1) The raw agricultural commodity bananas, when examined for pesticide residues, shall not include any crown tissue or stalk.
(2) Shell shall be removed and discarded from nuts before examination for pesticide residues.
(3) Caps (hulls) shall be removed and discarded from strawberries before examination for pesticide residues.
(4) Stems shall be removed and discarded from melons before examination for pesticide residues.
(5) Roots, stems, and outer sheaths (or husks) shall be removed and discarded from garlic bulbs and dry bulb onions, and only the garlic cloves and onion bulbs shall be examined for pesticide residues.
(6) Where a tolerance is established on a root vegetable including tops and/or with tops, and the tops and the roots are marketed together, they shall be analyzed separately and neither the pesticide residue on the roots nor the pesticide residue on the tops shall exceed the tolerance level, except that in the case of carrots, parsnips, and rutabagas, the tops shall be removed and discarded before analyzing roots for pesticide residues.
(7) The crowns (leaves at the top of the fruit) shall be removed and discarded from pineapples before examination for pesticide residues.
(8) The term lima beans means the beans and the pod.
(9) The term peanuts means the peanut meat after removal of the hulls.
(10) For processed foods consisting primarily of one ingredient and sold in a form requiring further preparation prior to consumption (e.g., fruit juice concentrates, dehydrated vegetables, and powdered potatoes), the processed food to be examined for residues shall be the whole processed commodity after compensating for or reconstituting to the commodity's normal moisture content, unless a tolerance for the concentrated or dehydrated food form is included in this part. If there exists a tolerance for a specific pesticide on the processed food in its concentrated or dehydrated food form, for the purpose of determining whether the food is in compliance with that tolerance, the processed food to be examined for residues shall be the whole processed commodity on an ``as is'' basis.
(i) The term pesticide chemical shall have the meaning specified in FFDCA section 201(q)(1), as amended, except as provided in Sec. 180.4.
(j) The term negligible residue means any amount of a pesticide chemical remaining in or on a raw agricultural commodity or group of raw agricultural commodities that would result in a daily intake regarded as toxicologically insignificant on the basis of scientific judgment of adequate safety data. Ordinarily this will add to the diet an amount which will be less than 1/2,000th of the amount that has been demonstrated to have no effect from feeding studies on the most sensitive animal species tested. Such toxicity studies shall usually include at least 90-day feeding studies in two species of mammals.
(k) The term nonperishable raw agricultural commodity means any raw agricultural commodity not subject to rapid decay or deterioration that would render it unfit for consumption. Examples are cocoa beans, coffee beans, field-dried beans, field-dried peas, grains, and nuts. Not included are eggs, milk, meat, poultry, fresh fruits, and vegetables such as onions, parsnips, potatoes, and carrots.
(l) The term tolerance with regional registration means any tolerance which is established for pesticide residues resulting from the use of the pesticide pursuant to a regional registration. Such a tolerance is supported by residue data from specific growing regions for a raw agricultural commodity. Individual tolerances with regional registration are designated in separate subsections in 40 CFR 180.101 through 180.999, as appropriate. Additional residue data which are representative of the proposed use area are required to expand the geographical area of usage of a pesticide on a raw agricultural commodity having an established ``tolerance with regional registration.'' Persons seeking geographically broader registration of a crop having a ``tolerance with regional registration'' should contact the appropriate EPA product manager concerning additional residue data required to expand the use area.
(m) The term pesticide chemical residue shall have the meaning specified in FFDCA section 201(q)(2), as amended, except as provided in Sec. 180.4.
(n) The term food commodity means:
(1) Any raw agricultural commodity (food or feed) as defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act (FFDCA); and
(2) Any processed food or feed as defined in section 201(gg) of the FFDCA. [36 FR 22540, Nov. 25, 1971]
Editorial Note: For Federal Register citations affecting Sec. 180.1, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.